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- || Lybalvi (olanzapine/samidorphan) / Alkermes
Review, Journal: Olanzapine and Samidorphan Combination Treatment: A Systematic Review. (Pubmed Central) - Mar 8, 2022
OLZ/SAM-treatment is associated with mitigated weight-gain liability when compared to OLZ-monotherapy in adults with schizophrenia. Additional studies are needed to ascertain patient acceptability, appropriate selection and sequencing of OLZ/SAM in the treatment algorithms for adults with schizophrenia (and BD-I), as well as to determine cost-effectiveness and long-term metabolic effects.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, P1 data, Journal: Insulin and glucose metabolism with olanzapine and a combination of olanzapine and samidorphan: exploratory phase 1 results in healthy volunteers. (Pubmed Central) - Mar 3, 2022
OLZ/SAM appeared to mitigate some of olanzapine's unfavorable postprandial metabolic effects (e.g., hyperinsulinemia, elevated C-peptide) in this exploratory study. These findings supplement the body of evidence from completed or ongoing OLZ/SAM clinical trials supporting its role in the treatment of schizophrenia and bipolar I disorder.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, PK/PD data, Journal: Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia. (Pubmed Central) - Feb 17, 2022
Consistent with the known metabolic pathways for olanzapine (primarily via uridine 5'-diphospho-glucuronosyltransferase [UGT]-mediated direct glucuronidation and cytochrome P450 [CYP]-mediated oxidation) and for samidorphan (predominately mediated by CYP3A4), coadministration of OLZ/SAM with rifampin, a strong inducer of CYP3A4 and an inducer of UGT enzymes, significantly decreased the systemic exposure of both olanzapine and samidorphan. Severe renal impairment or moderate hepatic impairment resulted in modest increase in olanzapine and samidorphan exposure.
- ||||| Lybalvi (olanzapine/samidorphan) / Alkermes
Enrollment closed: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (clinicaltrials.gov) - Feb 11, 2022
P3, N=500, Active, not recruiting, Sponsor: Alkermes, Inc.
Severe renal impairment or moderate hepatic impairment resulted in modest increase in olanzapine and samidorphan exposure. Enrolling by invitation --> Active, not recruiting
- | Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
Journal: Olanzapine/samidorphan (Lybalvi) for schizophrenia and bipolar disorder. (Pubmed Central) - Feb 8, 2022
Enrolling by invitation --> Active, not recruiting No abstract available
- || Lybalvi (olanzapine/samidorphan) / Alkermes
PK/PD data, Journal: Using Physiologically Based Pharmacokinetic Modeling for Predicting the Effects of Hepatic Impairment on the Pharmacokinetics of Olanzapine and Samidorphan Given as a Combination Tablet. (Pubmed Central) - Feb 1, 2022
In applying the optimized model, mild, moderate, and severe hepatic impairment were predicted to increase steady-state total exposures by 1.1-, 1.5-, and 1.6-fold, respectively, for olanzapine, and by 1.2-, 1.9-, and 2.3-fold, respectively, for samidorphan. PBPK modeling allowed for prediction of untested clinical scenarios of varying degrees of hepatic impairment in lieu of additional clinical studies.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, Journal: Long-Term Safety and Durability of Effect With a Combination of Olanzapine and Samidorphan in Patients With Schizophrenia: Results From a 1-Year Open-Label Extension Study. (Pubmed Central) - Jan 11, 2022
PBPK modeling allowed for prediction of untested clinical scenarios of varying degrees of hepatic impairment in lieu of additional clinical studies. No abstract available
- ||||||| Lybalvi (olanzapine/samidorphan) / Alkermes
Trial completion: Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder (clinicaltrials.gov) - Jan 10, 2022
P3, N=428, Completed, Sponsor: Alkermes, Inc.
No abstract available Active, not recruiting --> Completed
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical data, Journal: A Combination of Olanzapine and Samidorphan in Adults with Schizophrenia and Bipolar I Disorder: Overview of Clinical Data. (Pubmed Central) - Dec 30, 2021
Data across 18 OLZ/SAM studies in >1600 subjects support an antipsychotic efficacy and safety profile for OLZ/SAM that is similar to olanzapine, with significantly less weight gain than olanzapine. OLZ/SAM is a potential new treatment for schizophrenia and BD-I patients needing efficacious long-term treatment with reduced risk of weight gain.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Review, Journal: Olanzapine/Samidorphan: First Approval. (Pubmed Central) - Dec 22, 2021
Olanzapine/samidorphan (LYBALVI) was recently approved in the USA for the treatment of schizophrenia and bipolar I disorder. This article summarizes the milestones in the development of samidorphan leading to this first approval of olanzapine/samidorphan.
- || Rexulti (brexpiprazole) / Lundbeck, Otsuka
Review, Journal: New Antipsychotic Medications in the Last Decade. (Pubmed Central) - Dec 16, 2021
We identified 11 significant developments: the introduction of new antipsychotics cariprazine, brexpiprazole, lumateperone, and pimavanserin; introduction of new delivery subcutaneous long-acting risperidone, aripiprazole lauroxil, transdermal asenapine, and inhaled loxapine; and the introduction of new approaches such as olanzapine/samidorphan for olanzapine-associated weight gain, examination of the TAAR1 agonist SEP 363,856 as a test of concept, and the combination of Xanomeline/Trospium, an M and M muscarinic receptor agonist in conjunction with a peripheral anticholinergic. Last decade has seen a tremendous development in second-generation antipsychotics which provides unprecedented treatment options for clinicians in treating psychosis.
- olanzapine / Generic mfg.
Reduced Risk Across Multiple Cardiometabolic Risk Factors With OLZ/SAM Compared With Olanzapine: Results From a 24-Week Phase 3 Study ([VIRTUAL]) - Nov 28, 2021 - Abstract #ACNP2021ACNP_1259;
Background : The olanzapine and samidorphan (OLZ/SAM) combination was developed to mitigate olanzapine-associated weight gain while maintaining antipsychotic efficacy. Patients in ENLIGHTEN-2 were less likely to experience worsening of certain clinically relevant cardiometabolic risk factors when treated with OLZ/SAM vs olanzapine.
- olanzapine / Generic mfg.
Reduced Risk Across Multiple Cardiometabolic Risk Factors With OLZ/SAM Compared With Olanzapine: Results From a 24-Week Phase 3 Study (Exhibit Hall C) - Nov 28, 2021 - Abstract #ACNP2021ACNP_161;
Background : The olanzapine and samidorphan (OLZ/SAM) combination was developed to mitigate olanzapine-associated weight gain while maintaining antipsychotic efficacy. Patients in ENLIGHTEN-2 were less likely to experience worsening of certain clinically relevant cardiometabolic risk factors when treated with OLZ/SAM vs olanzapine.
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Retrospective data, Journal: A meta-analysis comparing short-term weight and cardiometabolic changes between olanzapine/samidorphan and olanzapine. (Pubmed Central) - Oct 31, 2021
Current evidence is insufficient to support the use of samidorphan to prevent olanzapine-induced weight gain and olanzapine-induced cardiometabolic abnormalities. Samidorphan is well accepted by olanzapine-treated patients.
- |||||| Lybalvi (olanzapine/samidorphan) / Alkermes
Enrollment open: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (clinicaltrials.gov) - Oct 26, 2021
P3, N=236, Enrolling by invitation, Sponsor: Alkermes, Inc.
Samidorphan is well accepted by olanzapine-treated patients. Not yet recruiting --> Enrolling by invitation
- || Lybalvi (olanzapine/samidorphan) / Alkermes
PK/PD data, Journal: Application of Physiologically Based Pharmacokinetic Modeling to Predict the Effect of Renal Impairment on the Pharmacokinetics of Olanzapine and Samidorphan Given in Combination. (Pubmed Central) - Oct 20, 2021
Not yet recruiting --> Enrolling by invitation Physiologically based pharmacokinetic modeling extended the findings from a clinical study in severe renal impairment to other untested clinical scenarios; these data could be of interest to clinicians treating patients with renal impairment.
- |||| Lybalvi (olanzapine/samidorphan) / Alkermes
Trial completion date, Trial primary completion date: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (clinicaltrials.gov) - Oct 4, 2021
P3, N=500, Enrolling by invitation, Sponsor: Alkermes, Inc.
Physiologically based pharmacokinetic modeling extended the findings from a clinical study in severe renal impairment to other untested clinical scenarios; these data could be of interest to clinicians treating patients with renal impairment. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, Review, Journal: An Evidence-Based Review of OLZ/SAM for Treatment of Adults with Schizophrenia or Bipolar I Disorder. (Pubmed Central) - Sep 18, 2021
As OLZ/SAM contains the opioid antagonist samidorphan, it is contraindicated in patients using opioids and in those undergoing acute opioid withdrawal. Clinical trial results from more than 1600 subjects support the use of OLZ/SAM as a new treatment option for patients with schizophrenia or BD-I.
- ||||| Lybalvi (olanzapine/samidorphan) / Alkermes
Enrollment closed: Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder (clinicaltrials.gov) - Aug 23, 2021
P3, N=425, Active, not recruiting, Sponsor: Alkermes, Inc.
Clinical trial results from more than 1600 subjects support the use of OLZ/SAM as a new treatment option for patients with schizophrenia or BD-I. Recruiting --> Active, not recruiting
- |||||||||| Lybalvi (olanzapine/samidorphan) / Alkermes
New P3 trial: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects (clinicaltrials.gov) - Aug 3, 2021
P3, N=236, Not yet recruiting, Sponsor: Alkermes, Inc.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
New P1 trial: Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder (clinicaltrials.gov) - Aug 3, 2021
P1, N=16, Recruiting, Sponsor: Alkermes, Inc.
- ||| Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, P3 data, Journal: A phase 3, multicenter study to assess the 1-year safety and tolerability of a combination of olanzapine and samidorphan in patients with schizophrenia: Results from the ENLIGHTEN-2 long-term extension. (Pubmed Central) - Jul 14, 2021
P3
OLZ/SAM was generally well tolerated over 52 weeks. Weight, waist circumference, metabolic laboratory parameters, and schizophrenia symptoms remained stable throughout the study.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
PK/PD data, Journal: Physiologically Based Pharmacokinetic Modeling for Predicting Drug Interactions of a Combination of Olanzapine and Samidorphan (OLZ/SAM). (Pubmed Central) - Jun 22, 2021
CYP3A4 induction is predicted to reduce both samidorphan and olanzapine exposure. CYP1A2 inhibition or induction is predicted to increase or decrease, respectively, olanzapine exposure only.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, Journal, Interview: Qualitative Clinical Trial Exit Interviews Evaluating Treatment Benefit, Burden, and Satisfaction in Patients with Schizophrenia. (Pubmed Central) - Jun 16, 2021
P3
This qualitative interview approach provided valuable insight into patients' experiences with previous medications and OLZ/SAM. Overall, most patients reported treatment satisfaction and improvements in symptoms, function, and health-related quality of life with OLZ/SAM.
- ||| Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, P3 data, Journal: Phase 3 Safety and Tolerability Results of the Combination Olanzapine and Samidorphan in Patients with Schizophrenia: The 1 Year ENLIGHTEN-2-Extension. (Pubmed Central) - Jun 16, 2021
P3
OLZ/SAM was generally well tolerated over 52 weeks. Weight, waist circumference, metabolic laboratory parameters, and schizophrenia symptoms remained stable throughout the study.
- ||| Lybalvi (olanzapine/samidorphan) / Alkermes
FDA event: $ALKS Announces FDA Approval of LYBALVI for the Treatment of Schizophrenia and Bipolar I Disorder (Twitter) - Jun 1, 2021
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, P1 data, Journal: Combination of olanzapine and samidorphan has no clinically relevant effects on ECG parameters, including the QTc interval: Results from a phase 1 QT/QTc study. (Pubmed Central) - Apr 29, 2021
Weight, waist circumference, metabolic laboratory parameters, and schizophrenia symptoms remained stable throughout the study. This thorough QT study in patients with stable schizophrenia demonstrated that OLZ/SAM, in doses and plasma concentrations up to supratherapeutic levels, does not have a clinically relevant effect on ECG parameters, including QT/QTc prolongation.
- samidorphan (ALKS 33) / Alkermes
[VIRTUAL] Population Pharmacokinetic-Pharmacodynamic Analysis to Explore the Concentration-Response Relationship in Patients with Schizophrenia Treated with Olanzapine Alone or in Combination with Samidorphan () - Apr 13, 2021 - Abstract #ASCP2021ASCP_156;
Furthermore, olanzapine-associated weight gain did not correlate with olanzapine dose or plasma concentration. Lastly, the effect of OLZ/SAM on mitigation of olanzapine-associated weight gain was not affected by inter-subject variability in olanzapine and/or samidorphan plasma concentrations.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Olanzapine/Samidorphan Mitigates Weight Gain Across Subgroups of Patients Known to Be at Increased Risk for Weight Gain With Olanzapine Treatment () - Apr 13, 2021 - Abstract #ASCP2021ASCP_155;
Baseline demographics were similar across treatment groups. OLZ/SAM was associated with a lower percent change in weight vs olanzapine at week 24 across all subgroups evaluated, with least squares mean differences (95% CI) of −2.38% (−3.88%, −0.88%) in the overall population, −2.73% (−4.45%, −1.01%) for males (n=391), −1.53% (−4.43%, 1.38%) for females (n=147), −3.43% (−7.00%, 0.13%) for age <30 years (n=98), −2.14% (−3.78%, −0.51%) for age ≥30 years (n=440), −2.37% (−4.10%, -0.63%) for black patients (n=392), −2.41% (−5.28%, 0.46%) for non-black patients (n=146), −2.17% (−4.10%, −0.24%) with BMI <27 kg/m2 (n=327), and −2.70% (−5.01%, −0.39%) with BMI ≥27 kg/m2 (n=211).
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Utilizing a Structured Benefit-Risk Assessment to Evaluate a Combination of Olanzapine and Samidorphan for the Treatment of Schizophrenia and Bipolar I Disorder () - Apr 13, 2021 - Abstract #ASCP2021ASCP_154;
In ENLIGHTEN-2, OLZ/SAM had reduced risks of weight gain and waist circumference increase compared to olanzapine along with similar risks of relapse and psychiatric discontinuation and no difference in metabolic worsening, neutropenia, hyperprolactinemia, orthostatic hypotension, sedation, and movement disorders. Based on this assessment, OLZ/SAM has comparable efficacy and a consistent safety profile to olanzapine with reduced weight gain.
- samidorphan (ALKS 33) / Alkermes
[VIRTUAL] In Vivo Characterization of the Opioid Receptor Binding Profiles of Samidorphan and Naltrexone in Rats: Comparisons at Clinically Relevant Concentrations () - Apr 13, 2021 - Abstract #ASCP2021ASCP_63;
Learning Objectives 1. Describe the binding profile of samidorphan at μ-, κ-, and δ-opioid receptors 2.
- olanzapine / Generic mfg.
[VIRTUAL] Reduced Risk Across Multiple Cardiometabolic Risk Factors With OLZ/SAM Compared With Olanzapine: Results From a 24-Week Phase 3 Study () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1853;
Background : The olanzapine and samidorphan (OLZ/SAM) combination was developed to mitigate olanzapine-associated weight gain while maintaining antipsychotic efficacy. Patients in ENLIGHTEN-2 were less likely to experience worsening of certain cardiometabolic risk factors when treated with OLZ/SAM.
- Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
[VIRTUAL] Long-Term Safety of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 2 and 3 Studies () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1851;
Patients in ENLIGHTEN-2 were less likely to experience worsening of certain cardiometabolic risk factors when treated with OLZ/SAM. OLZ/SAM was well tolerated in adults with schizophrenia for up to 3 years of treatment.
- olanzapine / Generic mfg.
[VIRTUAL] Reduced Risk Across Multiple Cardiometabolic Risk Factors With OLZ/SAM Compared With Olanzapine: Results From a 24-Week Phase 3 Study () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1535;
Background : The olanzapine and samidorphan (OLZ/SAM) combination was developed to mitigate olanzapine-associated weight gain while maintaining antipsychotic efficacy. Patients in ENLIGHTEN-2 were less likely to experience worsening of certain cardiometabolic risk factors when treated with OLZ/SAM.
- Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
[VIRTUAL] Long-Term Safety of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 2 and 3 Studies () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1533;
Patients in ENLIGHTEN-2 were less likely to experience worsening of certain cardiometabolic risk factors when treated with OLZ/SAM. OLZ/SAM was well tolerated in adults with schizophrenia for up to 3 years of treatment.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Weight and Metabolic Effects of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 3 Studies () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1206;
P3
After an initial 4-6 weeks, weight stabilized with long-term OLZ/SAM treatment in patients with schizophrenia. Waist circumference and metabolic parameters exhibited long-term stability over 76 weeks.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Antipsychotic Efficacy of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 3 Studies () - Apr 10, 2021 - Abstract #SOBP2021SOBP_1205;
P3
Waist circumference and metabolic parameters exhibited long-term stability over 76 weeks. Integrated efficacy data indicate that OLZ/SAM provides enduring antipsychotic effectiveness in patients with schizophrenia.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Weight and Metabolic Effects of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 3 Studies () - Apr 10, 2021 - Abstract #SOBP2021SOBP_888;
P3
After an initial 4-6 weeks, weight stabilized with long-term OLZ/SAM treatment in patients with schizophrenia. Waist circumference and metabolic parameters exhibited long-term stability over 76 weeks.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Antipsychotic Efficacy of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 3 Studies () - Apr 10, 2021 - Abstract #SOBP2021SOBP_887;
P3
Waist circumference and metabolic parameters exhibited long-term stability over 76 weeks. Integrated efficacy data indicate that OLZ/SAM provides enduring antipsychotic effectiveness in patients with schizophrenia.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Weight and Metabolic Effects of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 3 Studies () - Apr 4, 2021 - Abstract #CPNP2021CPNP_71;
Integrated efficacy data indicate that OLZ/SAM provides enduring antipsychotic effectiveness in patients with schizophrenia. Previously Presented: American Society of Clinical Psychopharmacology 2020 (Virtual)
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Safety of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 2 and 3 Studies () - Apr 4, 2021 - Abstract #CPNP2021CPNP_70;
Previously Presented: American Society of Clinical Psychopharmacology 2020 (Virtual) Previously Presented: American Society of Clinical Psychopharmacology 2020 (Virtual)
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Antipsychotic Efficacy of Olanzapine and Samidorphan Combination in Patients With Schizophrenia: Pooled Analyses From Phase 3 Studies () - Apr 4, 2021 - Abstract #CPNP2021CPNP_69;
Previously Presented: American Society of Clinical Psychopharmacology 2020 (Virtual) Previously Presented: American Society of Clinical Psychopharmacology 2020 (Virtual)
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] A Combination of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Disorder: Overview of Clinical Data () - Apr 4, 2021 - Abstract #CPNP2021CPNP_58;
Previously Presented: American Society of Clinical Psychopharmacology 2020 (Virtual) Previously Presented: Psych 2020 (Virtual), NEI 2020 (Virtual)
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Weight and Metabolic Effects of Olanzapine and Samidorphan Combination in Patients with Schizophrenia: Pooled Analyses from Phase 3 Studies () - Mar 1, 2021 - Abstract #SIRS2021SIRS_749;
P3
Discussion After an initial 4 to 6 weeks of weight gain, weight stabilized with long-term OLZ/SAM treatment in patients with schizophrenia. Waist circumference and metabolic parameters exhibited long-term stability over 76 weeks in patients continuing treatment.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Weight and Metabolic Effects of Olanzapine and Samidorphan Combination in Patients with Schizophrenia: Pooled Analyses from Phase 3 Studies () - Mar 1, 2021 - Abstract #SIRS2021SIRS_623;
P3
Discussion After an initial 4 to 6 weeks of weight gain, weight stabilized with long-term OLZ/SAM treatment in patients with schizophrenia. Waist circumference and metabolic parameters exhibited long-term stability over 76 weeks in patients continuing treatment.
- Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
[VIRTUAL] Long-Term Safety of Olanzapine and Samidorphan Combination in Patients with Schizophrenia: Pooled Analyses from Phase 2 and 3 Studies () - Mar 1, 2021 - Abstract #SIRS2021SIRS_495;
Changes in metabolic laboratory parameters were generally small and stabilized with long-term treatment. Discussion OLZ/SAM was well tolerated in adults with schizophrenia for up to 3 years of treatment.
- olanzapine / Generic mfg.
[VIRTUAL] Reduced Risk Across Multiple Cardiometabolic Risk Factors With OLZ/SAM Compared With Olanzapine: Results From a 24-Week Phase 3 Study () - Mar 1, 2021 - Abstract #SIRS2021SIRS_481;
The risk of developing metabolic syndrome per ATP III criteria was also reduced with OLZ/SAM (OR [95% CI]: 0.55 [0.31, 0.99]). Discussion Patients in ENLIGHTEN-2 were less likely to experience worsening of certain cardiometabolic risk factors when treated with OLZ/SAM.
- Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
[VIRTUAL] Long-Term Safety of Olanzapine and Samidorphan Combination in Patients with Schizophrenia: Pooled Analyses from Phase 2 and 3 Studies () - Mar 1, 2021 - Abstract #SIRS2021SIRS_357;
Changes in metabolic laboratory parameters were generally small and stabilized with long-term treatment. Discussion OLZ/SAM was well tolerated in adults with schizophrenia for up to 3 years of treatment.
- olanzapine / Generic mfg.
[VIRTUAL] Reduced Risk Across Multiple Cardiometabolic Risk Factors With OLZ/SAM Compared With Olanzapine: Results From a 24-Week Phase 3 Study () - Mar 1, 2021 - Abstract #SIRS2021SIRS_343;
The risk of developing metabolic syndrome per ATP III criteria was also reduced with OLZ/SAM (OR [95% CI]: 0.55 [0.31, 0.99]). Discussion Patients in ENLIGHTEN-2 were less likely to experience worsening of certain cardiometabolic risk factors when treated with OLZ/SAM.
- Lybalvi (olanzapine/samidorphan) / Alkermes
[VIRTUAL] Long-Term Antipsychotic Efficacy of Olanzapine and Samidorphan Combination in Patients with Schizophrenia: Pooled Analyses from Phase 3 Studies () - Mar 1, 2021 - Abstract #SIRS2021SIRS_204;
P3
The mean (SD) change from baseline to week 76 in CGI-S score was −1.46 (1.22) for group 1 and −0.45 (0.65) for group 2. Discussion Integrated data from multiple studies provided evidence of enduring antipsychotic effectiveness in patients with schizophrenia who continued long-term OLZ/SAM treatment.